This relates, in general, to prosthetic devices for surgical implantation; and, more particularly, to improvements in devices and techniques employing breast implants comprising fluid inflatable bodies.
The inventor practices plastic surgery and it has been his observation that one of the most common complaints of patients who have had breast implants for cosmetic reasons is hardness of the implants, producing an unnatural, firm feeling of the breast; and that such harness may be due, at least in part, to the formation of a tight fibrous capsule around the implant, producing a squeezing constricting effect and causing firmness by this pressure on the contents of the implant. However, this fibrous reaction terminates after one or two months when the tissue reaction ceases and the size of the fibrous sac around the implant becomes stabilized without further shrinkage. One of the principal causes of this reaction is the postoperative formation of hematoma around the implant due to postoperative bleeding. If some of the contents of the implant are withdrawn at any time after the fibrous tissue reaction ceases, the implant will become soft and will remain so indefinitely. It is usually only necessary to remove a small part of the contents of the implant, 25-50 cc. of a total volume of 200-350 cc., to produce the desired effect of softening the implant to simulate the softness of normal breast tissue.
Another common problem is that patients who undergo implantation of silicone breast prostheses for cosmetic reasons often decide that they wish to have the breast made smaller or larger than the originally agreed size, at some later date. Both of these complications of breast surgery can be corrected by altering the volume of the fluid, saline or water, in the implant to satisfy the patient's requirements. However, such an alteration involves all of the discomfort, hazard and expense of the original operation and, since it creates a presumption that the original operation may not have been properly performed, creates an additional hazard of malpractice litigation.
Means is provided in connection with certain types of prior art prosthetic devices comprising flexible containers, such as disclosed, for example, in U.S. Pat. Nos. 3,600,718 to J. L. Boone, 3,852,832 to McGhan et al, 3,883,902 to H. W. Lynch and 3,919,724 to Sanders et al, for filling the device up to a desired volume of fluid, and then sealing it. However, in the devices mentioned, once the filling operation has been completed, the filler tube is no longer conveniently available for a subsequent operation to adjust the fluid volume, as the length of the filler tube has either been removed altogether, cut off and sealed at a short length, or directed internally into the prosthesis. Moreover, the insert valves for the filling procedure are either completely inaccessible without major surgery, or they are positioned in a disfiguring manner on the front portion of the prosthesis. In either case, the sealed end of the filler tube makes an additional lump in the prosthesis which may be unsightly or hard to the touch.
Another disadvantage realized in many of the breast implantation prostheses of the prior art types is that unless they are securely anchored to the tissues by complicated surgical procedures, such as described, for example, by McGhan et al, they tend to move about on the implantation site. This may give discomfort to the wearer, and raises additional problems if it is desired to locate the intake valve for subsequently adjusting the volume of fluid in the container.